Duns Number:080728314
Device Description: EverFlo Stationary Oxygen Concentrator with Ultrafill Oxygen Filling Station with OPI (Oxy EverFlo Stationary Oxygen Concentrator with Ultrafill Oxygen Filling Station with OPI (Oxygen Percentage Indicator), 230V, Switzerland
Catalog Number
1104000
Brand Name
EverFlo
Version/Model Number
EverFlo, w/Oxygen Percent Indicator, 230V, UltraFill, CH
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 21, 2022
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K061261
Product Code
CAW
Product Code Name
Generator, oxygen, portable
Public Device Record Key
20da2662-c3d3-4277-9c22-2bd3d7cd44b1
Public Version Date
October 24, 2022
Public Version Number
6
DI Record Publish Date
September 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 151 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3279 |